MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE, AngioDynamics Queensbury, NY 12804 USA --- COMMON/USUAL NAME: Percutaneous, implanted, long-term intravascular catheter; CLASSIFICATION NAME: Percutaneous, implanted, long-term intravascular catheter; Device Listing # D095274. PICC Catheters are utilized for Short or Long Term peripheral access to the Central Venous system for intravenous therapy and power injections of contrast media.
FDA Recall Z-0467-2012 · Posted 2012-01-11
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Recalling FirmAngiodynamics Worldwide Headquarters
Recall StatusTerminated
Product CodeLJS
Date Initiated2011-12-05
Date Terminated2012-09-27
Product Quantity16 units domestically
Reason for Recall
AngioDynamics distributed the affected PICC catheters that were beyond their expiration date.
Firm Action
AngioDynamics sent an "URGENT-MEDICAL DEVICE RECALL" letter dated December 2, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. A Recall Reply Form was attached to the letter for customers to complete and return to the firm via fax at 518-798-1360. Contact your local sales representative or AngioDynamics Customer Service at 800-772-6446 for questions regarding this notice.
Root Cause
Incorrect or no expiration date
Distribution Pattern
Nationwide Distribution-including the states of Florida, Georgia, Montana, and Tennessee.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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